Requisition ID: CLI007091
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merckuccess is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck is on a quest for cures and is committed to being the worldremier, most research-intensive biopharmaceutical company. Today, wedoubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merckeading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
The Assoc Director is responsible for providing coordination and leadership support for internal audits as well as Global Health Authority Inspections, on behalf of GDMS. Incumbent will also play a key role in Serious Quality Issue investigations and related Corrective and Preventative Actions under the supervision of the Director, in compliance with Merck Standard Operating Procedures (SOPs).
Qualifications Education: - At least B.A. or B.S. degree, preferably in Pharmacy, Nursing, Biological Sciences, or health care related discipline.
Required: - Minimum 8 years experience in Clinical Data Management or related industry experience preferred
- Strong knowledge of ICH and GCP guidelines
- Inspection experience
- Basic understanding of a quality management system
- Strong communication skills (written and oral communication)
- Strong sense of urgency and leadership abilities
- Ability to establish and maintain good working relationships with the different functional areas and work cross functionally as part of a team
- Ability to work under pressure
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and wecounting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, weinventing for life.
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Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
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Job: Clinical Data Management
Other Locations:
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck
